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Notification report


General information

Notification Number
B/CZ/10/2


This notification has been withdrawn by the notifier
28/03/2017


Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority
13/10/2010

Title of the Project
Field evaluation of sugar beet (Beta vulgaris) lines and hybrids derived from transformation event H7-1 tolerant to the herbicide glyphosate

Proposed period of release:
01/03/2011 to 31/12/2013

Name of the Institute(s) or Company(ies)
Zkusebni stanice Nechanice on behalf of SESVanderHave International B.V., ;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Spain; Slovak Republic;

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/ES/09/28; B/ES/10/02; B/SK/10/01;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
sugar beetchenopodiaceaebetabeta vulgarisvulgaris var. saccharifera

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
H7-1 expresses the CP4 EPSPS protein, derived from Agrobacterium sp. strain CP4, which provides tolerance to glyphosate.

Genetic modification

3. Type of genetic modification:
Insertion;

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
H7-1 contains the cp4 epsps gene which codes for the CP4 EPSPS protein derived from Agrobacterium sp. strain CP4. This protein confers tolerance to glyphosate.
Right border: A 21-25 bp nucleotide sequence that acts as the initial point of DNA transfer into plant cells originally isolated from A. tumefaciens pTiT37
P-FMV: The 35S promoter from a modified Figwort Mosaic Virus (FMV)
ctp2: Sequences encoding the chloroplast transit peptide from the ShkG gene of Arabidopsis thaliana encoding EPSPS
cp4 epsps: The 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) coding sequence from Agrobacterium sp. strain CP4
E9 3’: 3' nontranslated sequence from the ribulose-1,5-bisphosphate carboxylase small subunit (rbcs2) E9 gene of pea (Pisum sativum)
Left border: A 21-25 bp nucleotide sequence that delimits the T-DNA transfer into plant cells, originally isolated from A. tumefaciens plasmid pTi15955, a derivative of the octopine type plasmid pTiA6
ori-V: Origin of replication from the broad host range plasmid RK2 for plasmid maintenance in Agrobacterium
ori-322: Origin of replication from pBR322 for plasmid maintenance in E. coli
rop: A segment of plasmid pBR322 that represses the formation of RNA primer critical to maintenance of the plasmid in bacterial hosts such as E. coli
aadA: Bacterial gene encoding an aminoglycoside-modifying enzyme, 3' (9)-O-nucleotidyl-transferase from the transposon Tn7


6. Brief description of the method used for the genetic modification:
H7-1 was produced by Agrobacterium-mediated transformation of cotyledons of sterile sugar beet seedlings.

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not applicable.

Experimental Release

1. Purpose of the release:
This type of yield and observation trial is part of a normal breeding programme where lines and hybrid are extensively tested to develop the optimal varieties to address the needs of the grower for high performing varieties such as high yield, high white sugar extractability, low soil tare, tolerance to fungal and viral diseases in Czech Republic.

2. Geographical location of the site:
Nechanice, Region Kralovehradecky

3. Size of the site (m2):
maximum 2000 m2

4. Relevant data regarding previous releases carried out with the same GM-plant, if any, specifically related to the potential environmental and human health impacts from the release:
H7-1 sugar beet has been notified in Belgium, United Kingdom, Italy, the Netherlands, France, Germany and Spain under Part B of Directive 90/220/EEC and 2001/18/EC. Furthermore, H7-1 has been released for field-testing at several locations in the U.S.A., Canada, Russia, Chile, Czech Republic and Poland since 1998. These field trials were conducted to produce material for the regulatory studies and to assess agronomic performance (efficacy, selectivity, yield assessment).
Following rigorous regulatory assessment, environmental authorizations have been received in the U.S.A. (2005), Canada (2005), and Japan (2007) for H7-1 sugar beet.
The results of the described field-testings and post-marketing experience in these countries showed no evidence that H7 1 is likely to cause any adverse effects to human or animal health and the environment. Except for its tolerance to glyphosate, H7-1 does not differ from conventional sugar beet.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of H7-1 has shown that the risk of potential adverse effects on human health or the environment, resulting from the deliberate release of this sugar beet for field testing, is negligible:
• The risk of the introduced trait in H7-1 to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. The likelihood of unintended spreading of H7-1 in the non-agricultural environments is negligible, as sugar beet is neither persistent nor invasive and these parameters are unaltered when compared to conventional sugar beet.
• Outcrossing will be negligible since this application is for consent to cultivate H7-1 sugar beet for trial purposes, implying that sugar beet is grown for its vegetative root and the lifecycle is limited to the vegetative stage in agricultural production. Nevertheless, measures will be taken to avoid hybridization with other sugar beet plants and to prevent seed dissemination at harvest and during transportation (see Point E).
• As H7-1 sugar beet is herbicide tolerant it has no target organisms with which to interact, either directly or indirectly. Therefore, no characteristics that may cause any adverse environmental effects could be identified.
• Based on the well-characterised mode of action of the EPSPS enzymes and the confirmation through studies of no adverse effects found, it is highly unlikely that H7-1 sugar beet would be hazardous to non-target organisms. The ecological interactions with non-target organisms or the biochemical processes in soil are considered similar to the ones caused by conventional sugar beet.
• Any occupational health aspects of handling H7-1 are not different from conventional sugar beet. Additionally this sugar beet was shown not to cause any toxic or allergenic effects in humans or animals and to be as safe and nutritious as any other sugar beet without any consequences for the feed/food chain.
• The environmental impact of the cultivation, management and harvesting techniques applied in the planned trials is considered no different from the cultivation of any other sugar beet.


Brief description of any measures taken for the management of risks:
The trial site will be checked regularly by trained staff during the period of the deliberate release to destroy sugar beet plants showing signs of bolting before flowering and pollen emission.
The trial plot will be encircled by 5 m unsown strip and by 8 rows of maize.
Harvested plants will be sampled and measured in the field.
Plant material remaining after the harvest will be destroyed and will not be used for human food or animal feed. The sites will be monitored for one year after the release and any volunteer sugar beet appearing will be eliminated before flowering. During this year, sugar beet will not be grown on the former trial sites.
A field logbook will record all actions and observations made in the trial with respect to the management and stewardship in the trial.
In case any adverse environmental effects, linked to the deliberate release of H7-1 sugar beet, are observed during the period of the release, these will be reported immediately to the Competent Authorities.
At the end of the field-testing season, a report will be made available by the notifier to the Competent Authorities. This report will detail any unexpected adverse environmental effects that were observed during the general surveillance, if any, and further actions elicited as an effect of these findings, if applicable.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
18/02/2011 00:00:00
Remarks: